TROMALYT 300, PROLONGED-RELEASE HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TROMALYT 300 mg, prolonged-release hard capsules

(acetylsalicylic acid)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Tromalyt 300 mg and what is it used for
2. What you need to know before you take Tromalyt 300 mg
3. How to take Tromalyt 300 mg
4. Possible side effects
5. Storage of Tromalyt 300 mg
6. Contents of the pack and further information

1. What is Tromalyt 300mg and what is it used for

Tromalyt 300 mg belongs to a group of medicines called antiplatelet agents and its active ingredient is acetylsalicylic acid.

Tromalyt 300 mg is indicated to prevent the formation of thrombi in those patients who have previously suffered:

• Myocardial infarction.
• Chest angina.
• Non-hemorrhagic stroke.
• Surgical intervention, such as coronary angioplasty or coronary bypass.

2. Before taking Tromalyt 300mg

Do not take Tromalyt 300 mg:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medicine (included in section 6).
• if you have or have had gastric, duodenal ulcer, or recurring gastric disorders.
• if you have presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or products containing the tartrazine dye.

• if you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.

• if you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency)
• if you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.

• if you are being treated with blood coagulation medications (oral anticoagulants)

• if you are under 16 years old, unless explicitly indicated by a doctor, since the use of acetylsalicylic acid is related to the appearance of Reye's syndrome, a rare but serious disease.
• if you are in your third trimester of pregnancy.
• if you have uncontrolled severe heart failure
• if you are being treated with methotrexate
• if you are in the last three months of your pregnancy, you should not use doses higher than 100 mg per day (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Consult your doctor before taking this medicine if you are in any of the situations described below:

• if you have recently undergone surgery, including dental surgery.
• if you are going to undergo surgery, including dental surgery, in the next seven days.
• if you are taking anti-inflammatory drugs or other types of medications, as certain medications can interact with Tromalyt 300 mg and produce unwanted effects (see "Use of other medications")
• if you have high blood pressure, have reduced kidney, heart, or liver function, have blood coagulation disorders, or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or anti-rheumatic drugs.
• if you have a glucose-6-phosphate dehydrogenase deficiency.
• if you have rhinitis and/or urticaria.
• If skin or mucous membrane lesions appear, treatment should be interrupted immediately.
• In some cases, it may trigger gout attacks.

Renal and hepatic insufficiency

This medicine should not be used in patients with renal or hepatic insufficiency.

Children

This medicine should not be administered to children under 16 years old, unless explicitly indicated by a doctor. The use of acetylsalicylic acid in children under 16 years old is related to the appearance of Reye's syndrome, a rare but serious disease.

Elderly

No dose reduction is necessary in elderly patients.

Use of Tromalyt 300 mg with other medications:

Inform your doctor or pharmacist if you are using or have recently used or may need to use another medication, including medications purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• Medications used to prevent transplant rejection (cyclosporine and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other analgesics or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin.
• Medications used to treat gout (probenecid).
• Corticosteroids, as they may increase the risk of gastric bleeding
• Diuretics.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Certain medications for controlling high blood pressure.
• Medications to lower blood sugar levels
• Vancomycin, an antibiotic used in some infections).
• Interferon alpha.
• Lithium, used in some psychiatric diseases.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medications for epilepsy.

If administered together, metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

Interference with diagnostic tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Tromalyt 300 mg with food, drinks, and alcohol:

Take this medicine after meals or with some food and with sufficient liquid.

If you habitually consume large amounts of alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. per day), taking this medicine may cause gastric bleeding.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Tromalyt 300 mg should only be used during the first and second trimester of pregnancy unless it is strictly necessary and at the lowest possible doses, and the treatment time should be reduced to the minimum possible.

During the third trimester of pregnancy, it is contraindicated

If you continue or start treatment with Tromalyt 300 mg during pregnancy on the advice of your doctor, then use Tromalyt 300 mg according to your doctor's instructions and do not use a dose higher than recommended.

Pregnancy - last trimester

Do not take more than 100 mg per day if you are in the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby and cause the delivery to be delayed or prolonged more than expected.

If you take Tromalyt 300 mg at low doses (up to 100 mg per day inclusive), you will need strict obstetric control as indicated by your doctor.

Pregnancy - first and second trimester

Do not take Tromalyt 300 mg during the first six months of pregnancy unless it is absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy, Tromalyt 300 mg may cause kidney problems in the fetus, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

If you need treatment for more than a few days, your doctor may recommend additional checks.

It is excreted in breast milk, so its use is not recommended during the breastfeeding period due to the risk of adverse effects in the child.

Driving and using machines

No effects on the ability to drive and use machines have been described at the doses administered with this specialty.

Tromalyt contains sucrose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Tromalyt 300mg

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you think the action of Tromalyt 300 mg is too strong or too weak, tell your doctor or pharmacist.

The recommended dose is:

• Adults: 1 capsule per day (300 mg of acetylsalicylic acid) orally.

Take the capsules whole with the help of a little liquid, preferably during meals.

You can start treatment any day of the week, following the order established in the blister calendar, until complete cycles of four weeks are completed, according to the doctor's instructions.

• Elderly: Same as adults

• Patient with renal insufficiency: as advised by the doctor

Duration of treatment

Your doctor will indicate the duration of your treatment with Tromalyt 300 mg.

Do not suspend treatment before, as the expected beneficial results will not be obtained.

If you take more Tromalyt 300 mg than you should:

With very high doses above the recommended dose, you may experience headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea.

Consult your doctor or pharmacist immediately, who will advise you on the measures to take.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tromalyt 300 mg:

Do not take a double dose to make up for forgotten doses.

Take the forgotten capsule with another meal on the same day. If a whole day has already passed, continue treatment without taking the forgotten capsule.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding.

Frequent side effects:

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric disorders, nausea, vomiting.

• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rash, angioedema
• At high doses, a decrease in blood prothrombin levels that can cause bleeding (hypoprothrombinemia).

Uncommon side effects:

• Reye's syndrome in children under 16 years old with febrile processes, flu, or chickenpox
• Hepatic disorders, especially in patients with juvenile arthritis.

Frequency not known:

• Bleeding, including severe bleeding (e.g., cerebral hemorrhage)

Side effects in long-term treatments at high doses

The following may appear: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems. Treatment should be suspended immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

Allergic reactions

In patients who have presented an allergic reaction to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity (allergy) to these medications.

Cardiac disorders

Edema, hypertension, and heart failure.

Vascular disorders:

Bleeding, including severe bleeding (cerebral hemorrhage and gastrointestinal bleeding) and bleeding tendency (epistaxis, gum bleeding, purpura, etc.) with prolonged bleeding, post-procedure bleeding.

Gastrointestinal disorders

Diarrhea, flatulence, exacerbation of colitis and Crohn's disease, and gastritis

Disorders of the skin and subcutaneous tissue

Stevens-Johnson syndrome and toxic epidermal necrolysis

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tromalyt 300mg

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not store above 30°C.

Expiration date

Do not use this medicine after the expiration date that appears on the package after Cad or Exp. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tromalyt 300 mg

The active ingredient is 300 mg of acetylsalicylic acid in the form of prolonged-release micropellets.

The other components are:

Inert cores: Cornstarch and Sucrose 20:80 and Coating: Copovidone, Eudragit L 12.5, Ethylcellulose, and Triacetin.

The components of the capsules are titanium dioxide, gelatin, erythrosine, and indigo carmine

Appearance of the product and contents of the pack

Tromalyt 300 mg is presented in hard capsules. Each package contains 4 blister calendars with 7 capsules each.

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

ROTTAPHARM Ltd

Damastown Ind Park,

Mulhuddart, Dublin 15 (Ireland)

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:June 2025

Other sources of information:

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/